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Less cutting, same cure? new trial tests smaller surgery for rectal cancer

NCT ID NCT07038122

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether surgeons can safely remove less tissue during surgery for upper rectal cancer after patients have received pre-surgery therapy. About 874 adults with locally advanced rectal cancer will be randomly assigned to either standard or reduced surgical margins. The goal is to see if the smaller surgery is as effective at preventing cancer from coming back while being safer and easier to recover from.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
laparoscopic surgery with reduced resection margins
What this could lead to
If successful, this could allow surgeons to remove less tissue while still effectively treating rectal cancer, leading to faster recovery and fewer complications.
What could go wrong
This is an early-stage trial with 874 participants, and the reduced margins might not be as effective as standard surgery in preventing cancer return. Risks include surgical complications like leakage or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 874 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-80 years. 2. Histopathologically confirmed adenocarcinoma of the rectum or rectosigmoid junction. 3. Clinical stage cT3-4N+M0, with or without positive mesorectal fascia (MRF), with or without extramural vascular invasion (EMVI); Tumor location confirmed by imaging to be above the peritoneal reflection and by endoscopy to be in the upper rectum or rectosigmoid junction. 4. For patients with pMMR (proficient Mismatch Repair; immunohistochemistry shows expression of all four proteins: MSH1, MSH2, MSH6, PMS2) or MSS (Microsatellite Stable) status: Tumor downstaged to T≤3N0M0 after neoadjuvant chemotherapy or total neoadjuvant therapy (TNT). Chemotherapy regimens include, but are not limited to, FOLFOX6, CAPOX, or FOLFOXIRI. 5. For patients with dMMR (deficient Mismatch Repair; immunohistochemistry shows loss of expression in two or more of MSH1, MSH2, MSH6, PMS2) or MSI-H (Microsatellite Instability-High) status: Tumor downstaged to T≤3N0M0 after immunotherapy. 6. Pre-neoadjuvant therapy / Preoperative staging methods: All patients underwent contrast-enhanced CT for staging. Peri-rectal metastatic lymph nodes: defined as nodes with short-axis diameter ≥10 mm or exhibiting CT characteristics typical of metastasis. Preoperative chest, abdominal CT, and pelvic MRI ruling out distant metastasis. 7. No signs of bowel obstruction; OR bowel obstruction that has resolved following proximal diverting colostomy. 8. No prior colorectal surgery. 9. No prior chemotherapy or radiotherapy. 10. No prior treatment with biologic agents (e.g., monoclonal antibodies), immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies), or other investigational drugs. 11. Prior endocrine therapy: Allowed. 12. Signed informed consent form. Exclusion Criteria: 1. History of malignant colorectal tumor(s). 2. Requiring emergent surgery (e.g., due to bowel obstruction or intestinal hemorrhage). 3. Primary tumor invading adjacent organs/tissues precluding R0 resection. 4. Multifocal primary tumors. 5. Concurrent diagnosis of other active malignancy. 6. Participation in other clinical trials within 4 weeks prior to enrollment or current participation. 7. ASA physical status classification ≥ IV and/or ECOG performance status ≥ 2 (see Appendix for details). 8. Severe hepatic, renal, cardiopulmonary, or coagulation dysfunction, or significant comorbidities contraindicating surgery. 9. History of severe psychiatric disorders. 10. Pregnancy or lactation. 11. Uncontrolled preoperative infection. 12. Other clinical or laboratory conditions deemed by the investigator to render the patient unsuitable for the trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.